Time to Healing (TTH) of Vesicular Primary Lesion [ Time Frame: Assessed from time of treatment initiation through Day 14 ] [ Designated as safety issue: No ]

Healing was defined as the loss of crust (erythema may be present) as assessed by the investigator. TTH was the time from treatment initiation to healing as defined above and was assessed from the time of treatment initiation through Day 14. The primary vesicular lesion was the first developed lesion located on the lip and was not to have extended more than 1 cm outside the lip.

Secondary Outcome Measures:

Abortion of Primary Lesions [ Time Frame: Assessed from the time of treatment initiation through Day 14 ] [ Designated as safety issue: No ]

Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage.

TTH of Non-primary Lesions (Aborted Lesions Excluded) [ Time Frame: Assessed from the time of treatment initiation through Day 14 ] [ Designated as safety issue: No ]

TTH of non-primary lesions was defined as the time from treatment initiation to healing of all non-primary vesicular lesions. Non-primary lesions were those that developed in addition to and/or in 1 or more days after the primary vesicular lesion and that were located at least 1 cm from the primary lesion. Aborted lesions were not included in this parameter. TTH was to be assessed by the investigator.

Duration of Episode (DOE) [ Time Frame: Assessed from initiation of treatment to Day 14 ] [ Designated as safety issue: No ]

For patients who experienced a vesicular lesion, DOE was defined as the time from treatment initiation to healing of primary and secondary vesicular lesions (loss of crust). For subjects whose primary and secondary lesions were not vesicular in nature, DOE was defied as the time from treatment initiation to return to normal skin or to cessation of symptoms, whichever came last.

Time to Cessation of Symptoms [ Time Frame: Assessed from time of treatment initiation through Day 14 ] [ Designated as safety issue: No ]

Time to cessation of symptoms was defined as the time from treatment initiation to cessation of all symptoms: pain, burning, itching, tingling, tenderness and discomfort. It was to be assessed by the investigator.

TTH of Aborted Primary Lesions [ Time Frame: Assessed from time of treatment initiation through Day 14 ] [ Designated as safety issue: No ]

TTH of aborted primary lesions was defined as the time from treatment initiation to healing of the primary lesion (erythema or papule) or cessation of symptoms, whichever came last. It was to be assessed by the investigator.

Time to Recurrence of Non-aborted Lesions During 9-month Follow-up [ Time Frame: From time of initial healing through the 9-month follow-up ] [ Designated as safety issue: No ]

Time to recurrence was the time from the healing of all lesions of the initial episode to the occurrence of new lesions.

Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up [ Time Frame: From time of initial healing through the 9-month follow-up ] [ Designated as safety issue: No ]

Recurrence was the occurrence of new lesions and was evaluated in a subgroup of patients who agreed to record recurrences during the 9-month follow-up period.

Patients were asked to place a tick mark on a 10 centimeter VAS indicating their symptom intensity. Scale ratings ranged from a minimum of 0 (none at all) to a maximum of 10 (worst possible). The location of the tick mark from "0" was measured in millimeters (0 - 100) and recorded.

Patient Satisfaction With Treatment [ Time Frame: Assessed on Day 14 (or within 24 hours of healing) ] [ Designated as safety issue: No ]

At the end of study (Day 14 [or within 24 hours of healing]), patients were asked whether they were satisfied with treatment (yes/no).

Patient Assessment of Efficacy of the Treatment [ Time Frame: Assessed on Day 14 (or within 24 hours of healing) ] [ Designated as safety issue: No ]

At the end of study (Day 14 [ or within 24 hours of healing]), patients were asked to rate efficacy of treatment using a 4-point scale (inactive, mildly active, moderately active, or very active).

Oral diseases that might interfere with the evaluation of the efficacy or safety of the treatments, including gingivitis, parondotis, mucositis, oropharyngeal candidiasis…

History of infection known to be resistant to acyclovir family agents

Previous vaccination against herpes

Concomitant treatment likely to interfere with acyclovir

Allergy to any acyclovir containing agents

Immunocompromised condition, including HIV+

Unability to properly understand protocol requirements, to follow the study procedures, to complete the patient diary or to start the self-initiation of the treatment

Upper full or partial dentures with acrylic border in the canine fossa

Milk allergy or known history of hypersensitivity to one of the components of the products

Rare hereditary problems of galactose intolerance.

Lactase enzyme deficiency or glucose galactose malabsorption

Clinically significant abnormal level of serum creatinine

Patients whose occupations make them unlikely to return to the clinic within 24h of treatment initiation

Pregnancy or breast-feeding

Investigational drug or immunomodulator treatment in the 30 days prior randomisation

Prior enrollment in this study

Participation in another therapeutic trial evaluating new drugs or which could interfere with the evolution of herpes labialis or the evaluation of the drug in the study within preceding 30 day.

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769314